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  • 1.  Study Registration on clinicaltrials.gov

    Posted 25-Jan-2016 18:39

    Hello Everyone,

     

    I am seeking your input regarding whether or not the study we are about to launch requires registration on clinicaltrials.gov. Our product is an in vitro diagnostic device which is already cleared for marketing via the 510k process. We are conducting a study to support a change in CLIA complexity categorization. The study involves collecting a finger stick sample and a venipuncture (<10ml) sample from participants. The samples will be tested using our product to determine the level of an analyte in the sample. The participants will not be given any diagnosis or treatment based on the test result.

     

    I believe the study is exempt from registration as it does not meet the definition of “applicable device clinical trial” given as “a prospective clinical study of health outcomes comparing an intervention with a device subject to section 510(k)…” in 801. Health outcomes are not a part of the study in anyway and (in my opinion) testing samples with our product is not an intervention.

     

    What are your thoughts?

     

    Thank you!

    Duane

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    Duane Poorman
    Director of Regulatory Affairs
    Now Diagnostics, Inc.
    Springdale AR
    United States
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  • 2.  RE: Study Registration on clinicaltrials.gov

    Posted 25-Jan-2016 23:51
    Duane,

    To be subject to registration requirements at ClinicalTrials.gov, it has to meet four elements to satisfy the term an "Applicable Clinical Trial" under Section 801, FDAAA. 

    One of the four requirements to meet is a "prospective clinical study of health outcomes*."

    Your description fails to meet the definition of "health outcomes" as the primary purpose of your study is not to *evaluate the ability of your device to make a diagnosis of a disease or condition directly related to human health.

    Thus, the answer should be "not required."

    To document how it is determined, you may refer to "how to identify an "Applicable Clinical Trials."  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

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  • 3.  RE: Study Registration on clinicaltrials.gov

    Posted 26-Jan-2016 08:24
    Hi

    Another factor to consider is publication of results in which case clinicaltrials.gov registration is required by most journals.

    Phil Lavin

    Sent from Windows Mail




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  • 4.  RE: Study Registration on clinicaltrials.gov

    Posted 26-Jan-2016 11:56

    Yes, journals (ICMJE) require a broader spectrum of clinical trials to be registered than FDA does; still, though, "health outcomes" is part of the definition, so I agree that registration would not be required. 

    "The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events." Clinical Trial Registration

    Icmje remove preview
     
    Clinical Trial Registration
    The ICMJE's clinical trial registration policy is detailed in a series of editorials (see Updates and Editorials and FAQs). Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
    View this on Icmje >
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    Elaine Cooperstein
    San Leandro CA
    United States

    Original Message


  • 5.  RE: Study Registration on clinicaltrials.gov

    Posted 27-Jan-2016 09:20

    David, Phil, and Elaine,

    Thank you for your input and bringing up the other points of possible publication and the ICMJE’s definition of a clinical trial.

    Duane

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    Duane Poorman
    Director of Regulatory Affairs
    Now Diagnostics, Inc.
    Springdale AR
    United States

    Original Message